target population:patients with liver cirhosis and early-stagehepatocellular carcinoma
Aim:Evaluation of the benefit of oral branched chain amino acids in patients with hepatocellularcarcinoma undergoing local ablation treatment.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Assessment

Primary outcomes

Short- to mid-term effects of liver function and nutrition status during the post ablative period.

Key secondary outcomes

Time to tumor progression

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The patients in the BCAA group received BCAA orally administration before tumor ablation therapy until 1 month after the therapy.

Interventions/Control_2

The patients in the diet group received diet therapy with defined daily food intake.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Early-stage hepatocellular carcinoma(BCLC staging)
2)Compensated liver cirrhosis
3) Equal to or more than 20 years old.

Key exclusion criteria

Exclusion criteria are the presence of any one of the following: serum albumin <2.5mg dL, serum total bilirubin level <3mg/dL, hepatic encephalopathy of or above grade II, history of albumin infusion or receiving BCAA granules in the preceding 3 months, and bleeding varices.